Updated 07/16/2020

Frequently Asked Questions For The Committees

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Laboratory Animal Research  |  Biosafety Research  |  Human Subjects Research

 

Laboratory Animal Research

Frequently Asked Questions

IACUC

Will the Research Protections Office (RPO) continue to operate as usual?

The RPO and its Committees are operating through modified procedures. RPO staff are working remotely and are conducting regularly scheduled and ad hoc meetings via online conferencing. On-site educational programs have been cancelled until further notice.

When can I resume animal research activities?

The IACUC approved my new protocol and/or amendment, does that mean I can begin my work?

The IACUC continues to conduct reviews and approvals. However, only research that has been deemed essential by the Vice President for Research may continue work in the labs. This is in accordance with Governor Phil Scott’s Stay Home, Stay Safe executive order which directed the closure of in-person operations for all non-essential business. This directive went into effect on March 25, 2020.

My protocol approval is nearing expiration and I have not transitioned to UVMClick yet. What do I do? What will happen if my approval to use animals expires during the ramp down in research operations?

The Transitional Support Team is still actively reaching out to PIs 4-6 weeks prior to protocol expiration. The transition from InfoEd to Click is still occurring remotely and on schedule during this time. Meetings with PIs regarding the transition are being conducted either over the phone or through Microsoft Teams as needed. It is important that you respond to emails from the Transitional Support Team regarding the transition in order to avoid protocol expiration.

The IACUC will continue to review and approve transitioned protocols from remote locations.

If your protocol does expire, your animals will be maintained and cared for on the OACM Holding Protocol. Under this protocol, routine husbandry and veterinary care (e.g., veterinary medical care; assessment of animal health and well-being; provision of food, water, and clean cages; maintenance of appropriate environmental conditions) will be provided, and per diems will be charged. However, no experimental procedures will be performed during this time.

Who do I contact with animal-related compliance questions?

RPO and the IACUC will continue to provide services remotely. Should you have any questions, please contact Aubrie Clas or Abbey Dattilio via email. They use Microsoft Teams to do virtual face-to-face meetings when needed.

 

Animal Care

What plans are in place to ensure that the animals housed on campus will continue to receive care?

The Office of Animal Care Management (OACM) will maintain mechanisms for providing continued daily care to all animals housed on campus in the event of a natural disaster or other events that may interrupt normal business, including the COVID-19 situation. This includes continued veterinary medical care; assessment of animal health and well-being; provision of food, water, and clean cages; and maintenance of appropriate environmental conditions. Our top priority is to continue the provision of critical life support services that ensure animal welfare. With the closure of the University, animal care staff has begun an extended weekend schedule, with animal checks on Friday through Monday, and animal checks, cage changes, and cage wash on Tuesday, Wednesday, and Thursday.

Will I be able to access the animals in my facility during a research hibernation?

All research buildings have been placed on restricted access (Monday – Friday lock/unlock schedule will be secured 24/7 until further notice). All occupants including staff, faculty, students, and contractors will be able to access card read doors with a valid CATCard. Access to the animal facilities by research personnel will continue for all those who currently have access in order to facilitate ongoing essential research functions.

Are there any restrictions on use of PPE in the animal facility?

These are some guidelines for conserving PPE during this time;

  • OACM asks that you limit entering the animal facility even if you have approval to do essential research. This is in an effort to maintain social distancing standards as well as save PPE—multiple lab members should not gown up to go into animal rooms if your work can be completed by one lab member.
  • If you are working in HSRF and then in Given, save your PPE from HSRF to wear in Given (remove before walking through corridors).
  • Limit your visits to the animal facility by clustering your duties on specific days (e.g., every other day visits) when possible; if you need to enter the facility multiple times in the same day, please save and re-wear your PPE (not gloves).
  • Limit the number of lab members
  • If you find a damaged PPE item (especially masks with broken ear-loops) please set aside for OACM to repair. Ear loops can be re-glued.
  • DO NOT cover cages on carts with new gowns; cages should be covered with your used gown or a sheet/towel.
  • DO NOT take PPE from the Animal Facility for use elsewhere; there has been an increase in “missing” PPE in recent weeks.
  • Enlist OACM to help—we are already in the facility and will work with a representative from your lab to assist with some tasks (weaning, separating, breeding, etc.) for a reduced fee.
  • If you are entering a room just to retrieve a cage or quickly check something, please ask Animal Care for help—someone who is already gowned up can likely assist you.

How do I request veterinary care?

If you have an animal in need of immediate attention, the quickest means to get in touch with on-call veterinary staff is to locate an Animal Care staff member in your facility.

If you are unable to locate someone in your facility:

  • During business hours (Tuesday-Thursday 7 a.m. – 4:00 p.m.), call the Veterinary Technician office at 802-656-8708
  • Outside of business hours, call Dr. Ida Washington at 425-592-2397 or Alyssa Frizzell at 802-528-9460.

How will I be notified of any animal health issues during a hibernation in research operations?

Animal Care team members (e.g., husbandry personnel, veterinarians, veterinary technicians) will reach out to the individual designated as the PI and/or Primary contact in your IACUC approved protocol with any animal health issues requiring attention. Notifications will be sent using the contact information (i.e., email address, phone number) provided in the protocol.

What can I do now that the COVID-19 virus is disrupting my animal experiments?

  • Effective immediately, no additional studies/experiments or breedings may begin, unless specifically approved by your Dean and the VPR, so that we may minimize the number of animals requiring daily care (Note that IACUC approval processes remain intact for protocol changes and reviews).
  • Orders for acquiring additional animals, as well as imports and exports, are no longer being accepted.

What are the best methods for us to reduce our animal breeding colonies in response to the new directives?

If you are suspending breeding of commercially-available animals, try to conserve the fewest number of animals needed to maintain the strain or line.

Specifically:

  • Remove male breeders from breeding cages and identify the male.
  • Ideally, save the youngest weanlings of a strain (~3-5 weanlings, male and female in separate cages).
  • Save one cage of female weanlings (3-5 weanlings, ideally 6-8 weeks old or youngest available) and label the cages with a “Save for Breeding” note.
  • Save one cage of male weanlings (2-3 weanlings, ideally 6-8 weeks old or youngest available) and label the cages with a “Save for Breeding” note.
  • If possible, recombine females into socially-housed cages (up to 5 per cage); females from different strains may be combined if socially compatible. Consider euthanatizing males if there are several of the same strain to reduce the number of singly-housed animals.

For strains that need to be maintained by breeding:

  • It is recommended that you reduce the number of breeding cages to 2-3 cages and allow mice to continue to breed.
  • Pups should be euthanized prior to weaning except in cases in which breeder cages are being replaced due to age or poor breeding.

What is an example of maintenance activities that may be performed with animals?

Maintaining the viability of a breeding colony that includes irreplaceable lines or strains involves actions by critical personnel. This may include establishing breeder pairs, weaning of offspring, animal identification, and genotyping. All of these can be performed by a single member of the laboratory in a relatively short amount of time, and are considered “critical maintenance activities.” These activities and personnel must be approved by the Dean or VPR.

If personnel in my laboratory are not available to conduct animal procedures or monitoring (e.g., provision of special feed, post-operative care, tumor monitoring) can OACM provide these services?

  • OACM’s primary focus is to continue the provision of critical life support services that ensure animal welfare. This includes continuing veterinary medical care; assessment of animal health and well-being; provision of food, water, clean cages, and maintenance of appropriate environmental conditions.
  • While OACM staff may be able to perform some research support services on an emergency, case-by-case basis, our commitment and priority focus must remain with critical standard care services.

Accordingly, laboratories should take the following actions:

  • Do not bring animals to laboratories with the idea of maintaining them overnight;
  • If you have IACUC approval to house animals outside of the animal facility, ensure that OACM staff are aware of their location;
  • At the end of each day (i.e., before leaving) monitor your animals closely and euthanize those that are nearing endpoints (i.e., do not plan to euthanize them first thing the next morning); and
  • Maintain vigilant communication with your research team to ensure that each team member monitors his or her animals according to the duties and assignments outlined in your protocol.

Can OACM continue to feed my special diet during a ramp down in research operations?

  • OACM will continue to provide special diets if appropriate arrangements have been made with OACM staff. We will continue to do our best to provide special diets for which we have ready access.
  • If the diets are for clinical care (e.g., required to maintain animal welfare) OACM will continue to provide these as a priority.

Can I still proceed with terminal studies?

The primary focus for laboratory staff, unless a waiver has been granted to perform essential research, must be preparing for a ramp down in research operations. Our intent behind “no new experiments” is to avoid producing additional compromised animals that may require attention and care that will avert our focus from performing critical animal care services.

Can I still order supplies and medications from the OACM Business Office (e.g., isoflurane, Puralube® eye ointment, suture material)?

OACM will continue placing orders for the critical supplies needed to ensure animal health and well-being (e.g., feed, bedding, critical care veterinary supplies), but procurement of all noncritical supplies will be temporarily placed on hold unless you have approval from your Dean and VPR to continue to do research. Customers will be notified once normal purchasing operations resume.

Am I still able to take training classes through the OACM Training Core?

All in-person bio-method training classes have been cancelled until further notice

Can COVID-19 directly infect or impact research animals and/or present an exposure risk to personnel working with them?

  • While 2 dogs (Hong Kong) and 2 cats (one in Belgium and one in Hong Kong) living with people diagnosed with COVID-19 have been reported to have been infected with SARSCoV-2, infectious disease experts and multiple international and domestic human and animal health organizations continue to agree that there is no evidence at this point to indicate that, under natural conditions, pets spread COVID-19 to people. – Source: American Veterinary Medical Association (link is external) (AVMA)
  • The USDA National Veterinary Services Laboratories has confirmed the presence of SARS-CoV-2 in one tiger at a zoo in New York. Public health employees believe the large cats became ill after being exposed to a zoo employee who was actively shedding virus. No other animals in other areas of the zoo are exhibiting similar clinical signs. The USDA and CDC are monitoring this situation. – Source: AVMA (link is external)
  • Out of an abundance of caution, it is recommended that those ill with COVID-19 limit contact with animals until more information is known about the virus.
  • Although several new research articles have been disseminated showing that some domestic animals can be experimentally infected with SARS-CoV-2 and may transmit the virus to other animals in an experimental setting, it is important to note that:
    • Reported data is preliminary,
    • Studies include a very small number of animals in an experimental setting and, therefore,
    • Results from these studies should not be extrapolated to the potential for SARS-CoV-2 to naturally infect or be transmitted by companion animals kept as pets. – Source: AVMA (link is external)

 

 

Biosafety Research

Frequently Asked Questions

Will the Research Protections Office (RPO) continue to operate as usual?

The RPO and its Committees are operating through modified procedures. RPO staff are working remotely and are conducting regularly scheduled and ad hoc meetings via online conferencing.

On-site educational programs have been cancelled until further notice.

When can I resume my research activities?

The IBC approved my new registration and/or amendment, does that mean I can begin or continue my work?

The IBC continues to conduct reviews and approvals. However, only research that has been deemed essential by the Vice President for Research may continue work in the laboratories. At this time, laboratory activities related to COVID-19 research are the only laboratories that are allowed to be active. This is in accordance with Governor Phil Scott’s Stay Home, Stay Safe executive order which directed the closure of in-person operations for all non-essential business. This directive went into effect on March 25, 2020.

What will happen if my registration is near expiration during the ramp down in research operations?

The IBC will continue to review and approve continuing reviews remotely. Consequently, PIs and research teams must continue to submit their continuing review update through UVMClick. Reminders are sent, every 30 days beginning at 90 days, so a registration should not lapse during this time.

Who do I contact with compliance questions?

RPO and the IBC will continue to provide services remotely. Should you have any questions, please contact Aubrie Clas, Melanie Locher, or Abbey Dattilio via email. They use Microsoft Teams to do virtual face-to-face meetings when needed.

Where do I find information about laboratory safety during the hibernation in laboratory activities?

The Department of Risk Management has developed a webpage to provide laboratory personnel information about what to do when ramping down activities in the laboratory. There are suggestions for steps prior to a shutdown being declared, FAQs (frequently asked questions), and resources to ensure the laboratory is safely, temporarily shut down. This page can be accessed by following this link https://www.uvm.edu/riskmanagement/covid-19-laboratory-information.

I am planning to work with COVID-19/SARS-COV-2 associated materials what do I need to do?

In response to the COVID-19 pandemic that is impacting public health worldwide, the "call" has gone out to the scientific research community to develop screening tests and therapeutics, as well as studies to better understand the virus itself.

If you are planning to work with COVID-19 clinical specimens or SARS-CoV-2 associated materials, it is important to obtain Vice President of Research approval, have a risk assessment completed and an IBC registration approved prior to accepting any of these materials in the laboratory

 

Human Subjects Research

Frequently Asked Questions

 

General

Will the Research Protections Office (RPO) continue to operate as usual?

The RPO and its Committees are operating through modified procedures. RPO staff are working remotely and are conducting regularly scheduled and ad hoc meetings via online conferencing. On-site educational programs have been cancelled until further notice.

 

Resumption of Research Activities

When can I resume my research activities?

As of July 6, all research may resume. However, research must meet requirements as outlined in the July 6th notices from the LCOM Dean, for the LCOM departments, and the VPR for all other departments.

What do I need to do to enroll new participants and/or restart ongoing participants?

The rollout has been in phases. The current phase, Phase III, is the last phase of resumption. Because of the phased rollout, different departments have different requirements to restart.

Larner College of Medicine (LCOM)

If COVID-19 mitigation processes will result in changes to your protocol or processes you must submit a modification (MOD) related to these changes for IRB review and approval. Please identify within the modification if the changes are specific to COVID-19 and whether the planned changes are temporary or permanent. While not required as part of the IRB modification submission for projects under LCOM, approved safety plans may be uploaded as a document under other uploads. Once you receive IRB approval of this modification, you are ready to resume your research.

Agriculture and Life Sciences, Arts and Sciences, Business, Education and Social Services, Engineering and Mathematical Sciences, Environment and Natural Resources, Nursing and Health Sciences, Honors College, Graduate College
  1. Ensure that your department has obtained approval from UVM to return to work. Ensure all staff have completed UVM VOSHA training.
  2. Develop protocol-specific plan to address COVID-19 federal and state requirements. This plan should be entitled "COVID Mitigation Plan for Resumption of Research" and must be appended to the end of your currently approved protocol.
    Note: You do not need to revise text within your protocol, the appendix is sufficient and hopefully temporary.
  3. Obtain chair/dean approval of this plan.
  4. Submit a modification to the IRB with the protocol and the new mitigation appendix and documentation of chair/dean approval. The approval could be their signature on the plan or it can be an email.
  5. Once you receive IRB approval of this modification, you are ready to resume your research.

Do I need IRB approval to contact participants who are scheduled for an in-person visit to determine their COVID-19 exposure or symptoms?

Required CDC and State requirements for screening must be completed prior to any in-person research visits. The screening procedures do not need IRB approval. For non-LCOM departments, we would expect that the screening is part of an overall mitigation plan. If a participant endorses answers that may indicate exposure or symptoms, instruct them to contact their primary care physician.

Though the IRB has determined that researchers are not required to submit modifications to their protocols or consents to include COVID-19 screening, it is important that the participant be informed of these requirements and any changes prior to coming to campus.

The IRB has developed an information sheet to be sent to potential new or ongoing participants whose research visits have been paused. The information sheet informs the individual as to how they will be treated during their research visits as well as how study procedures may be postponed to further alleviate safety concerns to both the individual participant as well as others. The sheet also has an editable area to inform participants, as applicable, if they will be required to undergo a nasal swab testing for COVID-19 as this is now a requirement for many hospital procedures. Hospital PIs/coordinators must educate themselves as to which procedures require a COVID-19 test and the timing required prior to the procedure. Required COVID-19 testing should be part of the discussion with the participant during their pre-visit COVID-19 screening phone call.

I am able to conduct future follow up with the participants remotely. Do I need to submit an amendment to conduct remote follow up?

Yes, switching to remote follow up requires a modification to your approved protocol.

What platform should I use for remote visits?

The platform that is used is based upon the needs of the visit. For remote research visits combined with clinical assessment, clinician/researchers must use the UVMMC hospital approved software and procedures including obtaining informed consent for use of telemedicine services. Telemedicine visits may not be recorded per Vermont Law [18 V.S.A. § 9361].

UVM recommends that non-clinical researchers use an institutionally supported service for the highest level of security for the participant. Currently, UVM's primary institutionally supported services are: Microsoft Teams using either an @uvm.edu or @med.uvm.edu account or Zoom using an @med.uvm.edu account. It is important to note that the account you use for these services is what determines appropriateness of use and not the tool itself. Logging in to Teams or Zoom with a personal email or an account not listed above or using a non-approved service may not provide you with the level of privacy and security required for videoconferencing and are therefore, not approved. The use of other readily available options like Facetime, Google, Facebook are not institutionally supported and therefore not allowed for this purpose.

In addition to using an institutionally supported service, researchers must obtain participant consent to conduct remote visits by videoconferencing disclosing the potential risk of confidentiality. If your protocol allows to record the research visit, this must be disclosed to the participant prior to the remote session.

Once you've determined the service you should use and once you’ve obtained consent, be sure that you use it securely. Do not record the session unless approved to do so by protocol and patient consent, avoid the use of the chat functionality, ensure that you are giving the link to the appropriate person, never post the meeting information publicly, treat the contact information as protected information (email addresses, phone numbers, etc.) and remember that these tools should only be used for remote visits during this time of crisis unless you have obtained IRB approval to use this method going forward.

Can I move my consent process to remote?

In appropriate situations, a remote consenting process may be used. You will need to submit a modification to your protocol for review and approval. In certain minimal risk situations, it may be appropriate to request a waiver of consent documentation. Work with your IRB Analyst for appropriate options. E-consenting policy is currently under development.

References include:

 

 

Reporting/Notifications

Do I need to notify my sIRB of record?

You may need to notify the reviewing IRB of the resumption of research activities. Researchers should contact those IRBs for guidance.

Do I need to update my ClinicalTrials.gov study record?

If the Overall Recruitment Status and/or Individual Site Status of a UVM investigator-initiated clinical study registered on ClinicalTrials.gov is changing due to the COVID-19 situation, you should update the study record as you normally would, within 30 days of the change. If enrollment and/ or other study activities are "on pause" rather than under an official IRB suspension, consider still selecting Suspended, which will populate the Why Study Stopped data element, where you may then more clearly explain the status. Additional information regarding study record maintenance requirements is available on the Office for ClinicalTrials.gov website.

If you had updated ClinicalTrials.gov with the pause information, once you have begun your research again, you must update with this new information within 30 days.

Do I need to notify my sponsor?

If your sponsor requires notification, you may provide the institutional policy and or this set of frequently asked questions.

 

COVID-19 Activities

I have a new COVID research study that I wish to conduct. What do I need to do?

Develop and submit a protocol for review and approval. Address within the submission why the proposed research does not increase risk to participants, does not increase risk to non-clinical research staff, and does not require additional use of PPE resources necessary for clinical purposes. To help us prioritize incoming submissions, please include "COVID-19" in UVMClick project full and short title fields.

Can I amend my current protocol to add COVID activities? What do I need to do?

Yes, you can amend your protocol to add COVID activities. Address within the submission why the proposed amendment does not increase risk to participants, does not increase risk to non-clinical research staff, and does not require additional use of PPE resources necessary for clinical purposes. To help us prioritize incoming submissions, please include "COVID-19" in UVMClick amendment name.

Are my COVID-19 Related Activities Research?

The IRB is ready to assist researchers and clinical care providers who are planning COVID-19-related activities that may intersect or overlap with public health authority activities and/or FDA emergency authorizations for diagnostics. In some cases, IRB approval will not be required. The IRB can assess the circumstances, provide advice, and issue determination letters. Please contact your assigned IRB Analyst for more information.

For information regarding activities that are not considered Human Participant Research, please see the IRB site.

How do I find out if COVID-19 testing is required and what the current PPE requirements are for procedures occurring within the Medical Center? (Updated 6/26/20)

Hospital information regarding PPE is updated regularly. To find out whether COVID-19 testing is required and what PPE requirements are associated with certain procedures, please contact Travis.BeebeWoodard@uvmhealth.org.

If a COVID-19 test is required, what do I do about billing? (Updated 6/26/20)

It depends upon whether the COVID-19 test is being completed for clinical purposes or research purposes only.

If participants are coming in for a clinically related procedure that requires COVID-19 testing, are currently a study participant or will be enrolled in a research study, the cost of the test would be considered standard of care and billed to the patient or their insurance. If participants are coming in for a research-specific procedure (e.g. not clinically necessary for care or for a test that is being completed more often than what is standard) that requires COVID-19 testing, the cost of the test is not standard of care and must be billed to the research study. The billing plans for these protocols must be revised to include this testing. To update billing plans please contact Denise Quint in UVM Medical Center Compliance, Denise.Quint@uvmhealth.org.

What happens if the participant needs a COVID-19 test during screening for eligibility (i.e. no research flag in EMR yet?) (Updated 6/26/20)

If a COVID-19 test must be completed prior to study enrollment, this must be paid for by the study. PIs/coordinators must contact UVMMC Billing after the regular clinical order has been placed to ensure that the test is appropriately billed to the study and not billed to the participant.

 

Regulatory Resources

Where can I find information about the COVID-19 virus? (please note the information behind these links are updated daily so check back often)

 

Patient Facing Document Resources